FDA Corrective Action Preventive Action (CAPA)

Compliance with FDA regulations is a basic requirement, which is why organizations apply corrective and preventive actions to enhance their existing businesses. To continually improve a product's quality, organizations incorporate FDA CAPA software in their quality management system. MasterControl FDA CAPA is software system designed to be compliant with FDA regulations that helps in conducting a systematic investigation of issues and leads to the development of appropriate corrective and preventive actions.

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Issues are raised through different sources including customer complaints, internal management, audits, etc. It is important to resolve these issues and prevent their recurrence in order for the business to thrive. The FDA has developed regulatory policies that organizations must comply with to maintain compliant business practices in the market. Adherence to FDA regulations is not only mandatory but also vital in developing a quality system that meets industry best practices, such as automated CAPA launching. There are quite a number of FDA CAPA software solutions on the market but most of these applications don't cater to specific businesses. MasterControl FDA CAPA software is built to allow organizations to plan and execute a CAPA program that best meets their business requirements.

MasterControl corrective action software is entirely web-based which means that it can serve as a common point for different users to collaborate when deciding about the corrective and preventive actions for resolving issues. All CAPA-related documentation is available in virtual vaults within the centralized system repository. The process of updating, approving, and electronically signing off on documents is conveniently managed so that users are always provided with the latest version of any document and related approval statuses. MasterControl FDA CAPA software also helps in applying remedial corrections so that issues are prevented from recurring.

MasterControl prevention actions are distributed in different stages which help in better planning and enhanced manageability of the CAPAs in the system. In paper or hybrid systems, management usually faces the risk of losing relevant information as data is manually entered in CAPA forms. The MasterControl FDA CAPA solution allows for the automatic population of form fields which prevents data loss and minimizes the impact of human error. This allows management to decide on comprehensive corrective and preventive actions after analyzing the data as a whole.

GMPs and Validation in FDA CAPA Environments

CAPA is a concept widely used in Good Manufacturing Practices (GMP). It encourages organizations to improve their existing manufacturing methods so that the overall quality of manufactured products can be gradually enhanced. The alteration of existing standard operating procedures also allows for the elimination certain risks that are attached to issues. The advanced analytics available in MasterControl's FDA CAPA software allow users to perform thorough root cause analyses of issues that impact the health of an organization's business. This helps management understand the exact cause of deviations which leads to deriving solutions for similar problems. MasterControl CAPA helps address the vital causes behind issues so that management is able to develop a sound CAPA program and resolve issues simply and effectively.

MasterControl's unique validation approach is proven to meet FDA standards and dramatically reduces the time, resources, and costs involved in validation of the software. Product training and technical support for FDA corrective actions are also available.

About MasterControl's FDA Corrective Action Preventive Action

MasterControl Inc. is a global provider of GxP process, quality audit, FDA CAPA, and document management software solutions for life science companies. MasterControl products are easy to use, easy to deploy, easy to validate, and easy to maintain. They incorporate industry best practices for automating and connecting every stage of the product development cycle, while facilitating regulatory compliance. By combining an integrated platform with a continuum of risk-based FDA corrective action preventive action products and services, the MasterControl system can be managed effectively and efficiently.